ISO 8637-2:2024

ISO 8637-2:2024

April 2024
International standard Current

Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.This document does not apply to:—     haemodialysers, haemodiafilters or haemofilters;—     plasmafilters;—     haemoperfusion devices;—     vascular access devices.NOTE 1        Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.NOTE 2        Requirements for plasmafilters are specified in ISO 8637-3.

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Main informations

Collections

International ISO standards

Publication date

April 2024

Number of pages

28 p.

Reference

ISO 8637-2:2024

ICS Codes

11.040.40   Implants for surgery, prosthetics and orthotics

Print number

1
Sumary
Extracorporeal systems for blood purification - Part 2: Extracorporeal blood and fluid circuits for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators

This document specifies requirements for disposable extracorporeal blood and fluid circuits and accessories used in combination with haemodialysis equipment intended for extracorporeal blood treatment therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration.

This document does not apply to:

—     haemodialysers, haemodiafilters or haemofilters;

—     plasmafilters;

—     haemoperfusion devices;

—     vascular access devices.

NOTE 1        Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637-1.

NOTE 2        Requirements for plasmafilters are specified in ISO 8637-3.

Replaced standards (1)
ISO 8637-2:2018
July 2018
International standard Cancelled
Extracorporeal systems for blood purification - Part 2 : Extracorporeal blood circuit for haemodialysers, haemodiafilters and haemofilters

This document specifies requirements for the blood circuit for devices used in extracorporeal blood filtration therapies such as, but not limited to, haemodialysis, haemodiafiltration, haemofiltration and transducer protectors (integral and non-integral) intended for use in such circuits. This document does not apply to: — haemodialysers, haemodiafilters or haemofilters; — plasmafilters; — haemoperfusion devices; — vascular access devices; — blood pumps; — pressure monitors for the extracorporeal blood circuit; — air detection devices; — systems to prepare, maintain or monitor dialysis fluid; — systems or equipment intended to perform haemodialysis, haemodiafiltration, haemofiltration or haemoconcentration. NOTE 1 Requirements for haemodialysers, haemodiafilters, haemofilters and haemoconcentrators are specified in ISO 8637‑1, and requirements for plasmafilters are specified in ISO 8637‑3. NOTE 2 Extracorporeal blood tubing sets can also be used for other extracorporeal therapies such as haemoperfusion, plasmafiltration and plasma adsorption.

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